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NCT04886531 · ClinicalTrials.gov registry record · Phase 2
Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers
A Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, sponsored by Ruth O'Regan.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 4
- Study locations
NCT04886531: Recruiting Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, sponsored by Ruth O'Regan.
NCT04886531 is a Phase 2 study of Breast Cancer and HER2-positive Breast Cancer that is actively recruiting participants, run by Ruth O'Regan. The registered enrollment target is 30 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04886531, a Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, is actively recruiting participants, sponsored by Ruth O'Regan.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 4
- Study locations
Study Summary
Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for 24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase inhibitor alone or the combination of neratinib and an aromatase inhibitor. A breast biopsy will be performed prior to Day 1 of week 4 of treatment. Following surgery, patients will receive standard of care HER2-directed and endocrine therapy at the treating physician's discretion.
Primary Outcome
pCR is defined as the lack of all signs of invasive cancer in the breast removed during surgery
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Neratinib
- DRUG Letrozole (L) or Anastrozole (A)
Study Locations (4)
Illinois
- University of Illinois Cancer Center - Chicago
New York
- University of Rochester Medical Center - Rochester
Pennsylvania
- Penn State Cancer Institute - Hershey
Wisconsin
- University of Wisconsin - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-07-21 |
| Est. Completion | 2027-07 |
| Phase | Phase 2 |
What NCT04886531 shows while recruiting
NCT04886531 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Trastuzumab is the first listed.
NCT04886531 reports a single indexed study location in Illinois, New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04886531 about?
NCT04886531 is a clinical study titled "Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers". Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for 24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase inhibitor alone or the combination of neratinib and an aromatase inhibitor. A breast biopsy will be performed prior to Day 1 of wee...
What is the current status of trial NCT04886531?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2022-07-21. Estimated completion is 2027-07.
What conditions does trial NCT04886531 study?
This clinical trial studies the following conditions: Breast Cancer, HER2-positive Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer.
What interventions are being tested in trial NCT04886531?
The interventions under investigation include: Trastuzumab (DRUG), Neratinib (DRUG), Letrozole (L) or Anastrozole (A) (DRUG).
Who is sponsoring clinical trial NCT04886531?
This trial is sponsored by Ruth O'Regan, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04886531 being conducted?
This trial has 4 study locations across Illinois, New York, Pennsylvania, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04886531's enrollment target sits among peer trials
30 955th of 1224 higher than 227 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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